MAUDE Adverse Event Report: ABBOTT VASCULAR XIENCE SIERRA EVEROLIMUS ELUTING CORONARY STENT SYSTEM; DRUG ELUTING CORONARY STENT DELIVERY SYSTEM

Model Number	1550250-18
Medical Device Problem Codes	Difficult to Remove (1528); Material Rupture (1546); Difficult to Advance (2920)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/19/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned to abbott vascular for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot or relabeled lot that would have contributed to this event.Additionally, a review of the complaint history identified no other similar incidents and/or complaints reported from this lot or relabeled lot.In this case, the device was prepped prior to use with no issue/ leak noted, which would suggest that the device was not damaged prior to use.The investigation determined the reported difficulty to advance, difficulty to remove and material rupture appear to be related to operational circumstances of the procedure.Based on the reputed information, the challenging anatomical conditions which were reported as heavily calcified, 75% stenosed caused resistance during advancement of the sds, resulting in the reported difficulty to advance and remove.Manipulation against resistance with the anatomy during advancement likely caused the device to become damaged resulting in the material rupture.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
Event or Problem Description
It was reported that the procedure was to treat a heavily calcified, 75% stenosed, de novo lesion int the left anterior descending artery (lad).A 2.5x18mm xience sierra drug eluting stent (des) was advanced but met resistance with the anatomy and was unable to reach the target lesion.Dilatation was performed a second time and the des reached the lesion, but it was noted that blood was observed in the inflation device and a balloon rupture was suspected.The des was removed with resistance noted with the anatomy.A non-abbott device was used to successfully complete the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

• Brand Name: XIENCE SIERRA EVEROLIMUS ELUTING CORONARY STENT SYSTEM
• Common Device Name: DRUG ELUTING CORONARY STENT DELIVERY SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 10500241
• Report Number: 2024168-2020-07441
• Device Sequence Number: 18975534
• Product Code: NIQ
• UDI-Device Identifier: 08717648227103
• UDI-Public: 08717648227103
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• PMA/510(K) Number: P110019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/04/2021
• Device Model Number: 1550250-18
• Device Catalogue Number: 1550250-18
• Device Lot Number: 810264A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/19/2020
• Initial Report FDA Received Date: 09/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1